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Agilent's Opdivo CDx Gets Expanded CE Mark in Europe

NEW YORK (GenomeWeb) – Agilent Technologies announced today that its Dako PD-L1 IHC 28-8 pharmDx test, a companion diagnostic for Bristol-Myers Squibb's cancer drug Opdivo (nivolumab), has has received an expanded CE mark for use in Europe.

According to the company, the test can now be used in identifying patients with urothelial cancer who are most likely to benefit from Opdivo therapy. The test is already marketed in Europe for tumor cell PD-L1 expression for non-squamous non-small-cell lung cancer (ns-NSCLC), melanoma, and squamous cell carcinoma of the head and neck. 

The test is also approved in the US a complementary diagnostic for Opdivo for ns-NSCLC and for assessing the magnitude of benefit melanoma patients might derive from the drug.